RSS

ISO 13485

SEKO Logistics has gained ISO 13485 quality management certification for its facility in Amsterdam, as it aims to strengthen its service offering for medical device manufacturers and distributors. Read more

News

Electronic components provider Schurter has passed the initial ISO 13485 medical standard certification as well as the occupational health and safety standard ISO 45001. Read more

News

Medovate, the medical device company has achieved ISO 13485:2016 quality management system certification. Read more

News

precision micro.jpg

James Bastable

Photo etching component supplier Precision Micro has received ISO 13485 certification – the internationally recognised quality management system for medical device manufacturers. Read more

News

Global Electronics Manufacturing Services (EMS) specialist Chemigraphic has successfully transitioned to the new 2016 version of the medical device manufacturing standard, ISO 13485. Read more

News

Specialist chemical company Clariant has seen its recently expanded facility in Lewiston, Maine, and two other sites in Malmo, Sweden, and Singapore, certified to the new quality standard for makers of plastic medical devices. Read more

News

Chino.io, a cloud-based data security platform for digital health companies, has received ISO 13485 certification, a standard that defines that quality management systems (QMS) for manufacturers of medical devices. Read more

News

What makes a successful outsourcing partnership? Vladimir Timashov, Healthcare & Life Sciences, DataArt writes. Read more

Features

To help streamline regulatory processes for medical devices across the world, the FDA has decided to replace its current system with ISO 13485, the organisation has announced. Read more

News

The update to ISO 13485 doesn’t exactly make for light reading – which is why Med-Tech Innovation News asked Richard Poate, senior manager at notified body Tüv Süd for help in deciphering the revised standard. Read more

Features

Component supplier Reliance Precision has announced that it has now received ISO 13485 certification. The certification will allow the company to further develop its medical and life sciences business. Read more

News

RD Biomed, a Yorkshire-based medical tech company, announced it has achieved ISO 13485:2016 certification. Read more

News